Summary
The FDA issued a Class II for NexxZr T Multi A3.5 W98-16mm, REF: 745451 by Sagemax Bioceramics, Inc.. Reason: Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically .
Details
Source
Device Recall
External ID
Z-2356-2026
Action Date
2026-06-17
Status
Ongoing
Category
device
Product Description
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Lot/Code Info: UDI-DI: 00842271175373, Lot: YBDGLD
Quantity Affected: 113
Reason for Recall
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.
Distribution
Worldwide - US Nationwide distribution in the states of CA, MO, MN, NY, FL, ID and the countries of AT, CZ, DE, EE, EG, FR, GR, ID, IT, KZ, RS, SE, SI, TZ, VN.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-11
Company
Federal Way, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 228 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sagemax Bioceramics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sagemax Bioceramics, Inc. have FDA actions?
This is the only FDA action we have on record for Sagemax Bioceramics, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2356-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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